KR102132050B1 - 티엔에프알에프씨 융합 단백질의 안정한 약학 조성물 - Google Patents

티엔에프알에프씨 융합 단백질의 안정한 약학 조성물 Download PDF

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Publication number
KR102132050B1
KR102132050B1 KR1020157012856A KR20157012856A KR102132050B1 KR 102132050 B1 KR102132050 B1 KR 102132050B1 KR 1020157012856 A KR1020157012856 A KR 1020157012856A KR 20157012856 A KR20157012856 A KR 20157012856A KR 102132050 B1 KR102132050 B1 KR 102132050B1
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South Korea
Prior art keywords
composition
etanercept
phosphate
pharmaceutical composition
glycine
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Expired - Fee Related
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KR1020157012856A
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English (en)
Korean (ko)
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KR20150074069A (ko
Inventor
안잘리 디팩 압테-데쉬판데
바이바브 다이아네시바르 데오카르
러스톰 소랍 모디
Original Assignee
루핀 아틀란티스 홀딩스 에스에이
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Publication of KR20150074069A publication Critical patent/KR20150074069A/ko
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Toxicology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Inorganic Chemistry (AREA)
KR1020157012856A 2012-10-26 2013-10-24 티엔에프알에프씨 융합 단백질의 안정한 약학 조성물 Expired - Fee Related KR102132050B1 (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
IN1236/KOL/2012 2012-10-26
IN1236KO2012 2012-10-26
IN1235KO2012 2012-10-26
IN1235/KOL/2012 2012-10-26
PCT/IB2013/059612 WO2014064637A1 (en) 2012-10-26 2013-10-24 Stable pharmaceutical composition of tnfr:fc fusion protein

Publications (2)

Publication Number Publication Date
KR20150074069A KR20150074069A (ko) 2015-07-01
KR102132050B1 true KR102132050B1 (ko) 2020-07-10

Family

ID=54208810

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020157012856A Expired - Fee Related KR102132050B1 (ko) 2012-10-26 2013-10-24 티엔에프알에프씨 융합 단백질의 안정한 약학 조성물

Country Status (14)

Country Link
US (2) US10058589B2 (enrdf_load_stackoverflow)
EP (1) EP2919801B1 (enrdf_load_stackoverflow)
JP (1) JP6431844B2 (enrdf_load_stackoverflow)
KR (1) KR102132050B1 (enrdf_load_stackoverflow)
CN (1) CN104936607A (enrdf_load_stackoverflow)
AU (1) AU2013336279B2 (enrdf_load_stackoverflow)
BR (1) BR112015009462A2 (enrdf_load_stackoverflow)
CA (1) CA2889271A1 (enrdf_load_stackoverflow)
ES (1) ES2806946T3 (enrdf_load_stackoverflow)
MX (1) MX366622B (enrdf_load_stackoverflow)
PL (1) PL2919801T3 (enrdf_load_stackoverflow)
PT (1) PT2919801T (enrdf_load_stackoverflow)
RU (1) RU2664691C2 (enrdf_load_stackoverflow)
WO (1) WO2014064637A1 (enrdf_load_stackoverflow)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2007015476A (es) 2005-06-14 2008-02-25 Amgen Inc Formulaciones de proteina autoamortiguadoras.
SG11201508900UA (en) * 2013-05-02 2015-11-27 Mabxience S A Alternative formulations for tnfr: fc fusion polypeptides
JP6480154B2 (ja) * 2014-11-06 2019-03-06 持田製薬株式会社 エタネルセプトの凍結乾燥製剤
MX389818B (es) * 2015-08-13 2025-03-20 Landsteiner Scient S A De C V Composicion de estabilidad mejorada de etanercept.
US20190060241A1 (en) * 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
CN114917185B (zh) * 2016-10-21 2023-11-14 美国安进公司 药物配制品及其制备方法
EP3664893A1 (en) 2017-08-08 2020-06-17 CSL Behring AG Hemopexin formulations
CA3042126A1 (en) 2018-05-03 2019-11-03 Michael A. Portman Methods of treating kawasaki disease
WO2022264097A1 (en) 2021-06-17 2022-12-22 Lupin Limited Pharmaceutical composition of anti-tumour necrosis factor (anti-tnf) agent for management of infectious diseases caused by coronaviruses

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011141926A2 (en) * 2010-05-10 2011-11-17 Intas Biopharmaceuticals Limited Liquid formulation of polypeptides containing an fc domain of an immunoglobulin

Family Cites Families (12)

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US5215743A (en) 1988-04-13 1993-06-01 Maninder Singh Tumor necrosis factor formulations
US5997856A (en) * 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
DE4239877C1 (de) * 1992-11-27 1994-03-17 Boehringer Ingelheim Int Stabilisierte Superoxid-Dismutase (SOD)-Zusammensetzung
CA2304808C (en) * 1997-09-23 2011-03-22 Michael Tschope Liquid interferon-.beta. formulations
PT1946776T (pt) 2002-02-27 2017-03-17 Immunex Corp Composição de tnfr-fc estabilizada compreendendo arginina
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
RS51041B (sr) 2003-02-28 2010-10-31 Ares Trading S.A. Tečne formulacije tbp-1 proteina koji vezuju faktor tumorske nekroze
ES2310122B1 (es) * 2007-04-20 2009-10-30 Instituto Cientifico Y Tecnologico De Navarra, S.A Nanoparticulas que comprenden una ciclodextrina y una molecula biologicamente activa y sus aplicaciones.
CA2724510C (en) * 2008-04-30 2015-10-27 Wockhardt Research Centre Processes for refolding of insulin
JP2012526121A (ja) * 2009-05-04 2012-10-25 アボツト・バイオテクノロジー・リミテツド ヒト抗ｔｎｆアルファ抗体の安定した高蛋白質濃度製剤
SG190069A1 (en) 2010-11-11 2013-06-28 Abbvie Biotechnology Ltd IMPROVED HIGH CONCENTRATION ANTI-TNFa ANTIBODY LIQUID FORMULATIONS
WO2012143418A1 (en) * 2011-04-20 2012-10-26 Sandoz Ag STABLE PHARMACEUTICAL LIQUID FORMULATIONS OF THE FUSION PROTEIN TNFR:Fc

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011141926A2 (en) * 2010-05-10 2011-11-17 Intas Biopharmaceuticals Limited Liquid formulation of polypeptides containing an fc domain of an immunoglobulin

Also Published As

Publication number Publication date
CA2889271A1 (en) 2014-05-01
CN104936607A (zh) 2015-09-23
EP2919801A1 (en) 2015-09-23
US10058589B2 (en) 2018-08-28
RU2015119603A (ru) 2016-12-20
EP2919801B1 (en) 2020-04-29
MX2015005231A (es) 2015-10-29
WO2014064637A1 (en) 2014-05-01
US20150283241A1 (en) 2015-10-08
PT2919801T (pt) 2020-07-30
KR20150074069A (ko) 2015-07-01
JP2015535237A (ja) 2015-12-10
JP6431844B2 (ja) 2018-11-28
US20180236030A1 (en) 2018-08-23
ES2806946T3 (es) 2021-02-19
AU2013336279B2 (en) 2018-07-19
MX366622B (es) 2019-07-16
PL2919801T3 (pl) 2021-01-25
BR112015009462A2 (pt) 2017-07-04
AU2013336279A1 (en) 2015-05-14
RU2664691C2 (ru) 2018-08-21

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